About this trial
The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is an observational registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT). The purpose of this study is to better understand HHT, the symptoms and complications it causes, and the impact the disease has on people's lives. The investigators will collect long-term information about the participant, allowing us to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease.
Another important goal of the study is to provide a way to contact people to participate in future clinical trials and other research. The registry will be a centralized resource for recruitment for clinical trials. People in the registry will not be obligated to join any of these additional studies, but if interested, can agree to be contacted if they may be eligible for a study.
Participants will:
* Be asked to provide permission to collect information from their medical records, including things like demographic information, diagnosis information, family history, test results, treatment information, symptoms, complications, lifestyle and other relevant medical information. * Be asked study-related questions by phone or at a clinic visit. * Be asked study-related questions every year after enrollment for up to 10 years or until the study ends. A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous year/s including new test results, treatment information, symptoms, and complications from HHT.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with HHT based on the Curacao diagnostic criteria or genetic testing.
Able to provide informed consent or informed consent via a parent or legally authorized representative due to their age or medical condition.
Disqualifiers
Unable to provide informed consent or informed consent via a parent or legally authorized representative.
Trial population
All patients evaluated and diagnosed with HHT in the U.S. will be eligible to participate in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Comprehensive Baseline Data Collection using HHT Baseline Assessment Scale
Utilizing the "HHT Baseline Assessment Scale," this measure focuses on recruiting a diverse cohort of HHT patients across North America. Comprehensive baseline clinical, demographic, and lifestyle data will be collected and entered into CHORUS. The data, aggregated as mean change from baseline using the scale, will serve as a foundational resource for future clinical translational studies, addressing the urgent need for natural history data in HHT.
Prospective Longitudinal Clinical Outcomes Assessment using HHT Clinical Outcomes Scale
Utilizing the "HHT Clinical Outcomes Scale," this measure aims to prospectively and longitudinally assess the clinical outcomes of HHT patients. Determinants such as demographic factors, environmental influences, lifestyle choices, comorbidities, medications, HHT-genotype, and organ vascular malformations (VMs) will be measured. The data, aggregated as mean change from baseline using the scale, will enhance understanding and accelerate the development of new diagnostic and treatment options for HHT.
Secondary outcomes
Identify severe morbidity and mortality outcomes related to HHT using HHT Clinical Outcomes Scale
Description: Utilizing the "HHT Clinical Outcomes Scale," this measure aims to prospectively and longitudinally assess severe complications in HHT. This measure focuses on measuring rates of severe complications in HHT. Determinants of these complications will be characterized, and the data will be aggregated as mean change from baseline using the index, providing valuable insights into the disease progression.
Epistaxis Characterization with Epistaxis Severity Scale
Description: Utilizing the "Epistaxis Severity Scale," this measure aims to characterize epistaxis in adults with HHT, considering aspects such as frequency, duration, intensity, and variability. Outcome determinants related to epistaxis will be elucidated, and the data will be aggregated as mean change from baseline using the scale to inform comprehensive patient care.
Organ Vascular Malformation (VM) Development and Growth Assessment using Organ VMs Assessment Tool
Utilizing the "Organ VMs Assessment Tool," this measure involves the prospective measurement of the development and growth of organ vascular malformations (VMs) in HHT patients over time. Outcome determinants related to these VMs will be investigated, and the data will be aggregated as mean change from baseline using the tool, contributing to a better understanding of disease progression.
Treatment Outcomes Assessment with HHT Treatment Outcomes Scale
Utilizing the "HHT Treatment Outcomes Scale," this measure involves the prospective measurement of treatment outcomes for HHT and its clinical manifestations. Treatment outcome determinants will be characterized, and the data will be aggregated as mean change from baseline using the scale to guide effective management strategies for patients with HHT.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cure HHT
Lead sponsor
Augusta University
Collaborator
The Cleveland Clinic
Collaborator
Mayo Clinic
Collaborator
Massachusetts General Hospital
Collaborator
Columbia University
Collaborator
Oregon Health and Science University
Collaborator
University of California, Los Angeles
Collaborator
University of California, San Francisco
Collaborator
University of Colorado, Denver
Collaborator
University of North Carolina, Chapel Hill
Collaborator
University of Pennsylvania
Collaborator
University of Texas
Collaborator
University of Utah
Collaborator
Washington University School of Medicine
Collaborator
Yale University
Collaborator
Health Resources and Services Administration (HRSA)
Collaborator
University of Alabama at Birmingham
Collaborator